The present invention relates to a system and method for treatment of urinary tract disorders and, more particularly, to a device and method for insertion into a urethra and/or bladder that is capable of simultaneously delivering moderate heat, pressure, and/or drugs to provide relief in the pelvic area.
There is a wide array of urinary tract inflammatory disorders, which can generally be broken down into two categories: bacterial and non-bacterial. Bacterial inflammatory disorders are relatively easy to diagnose and treat. Non-bacterial inflammatory disorders are generally less understood, harder to diagnose, and harder to treat successfully. Symptoms usually include pelvic pain or discomfort, urinary urge or frequency, bladder pain, and even pain in neighboring parts of the body such as the abdomen, lower back or thighs. Patients presenting with such symptoms for whom bacterial causes have been ruled out may be diagnosed with one of the non-bacterial disorders. For example, a male disorder called chronic pelvic pain syndrome (CPPS), also known as chronic non-bacterial prostatitis, manifests itself in men as general pain or discomfort in the urethra, perineum, bladder area, penis, testicles, or general pelvic area. Similar symptoms typify another condition occurring mainly in women called interstitial cystitis (female to male ratio approximately 9:1), which is characterized by a non-bacterial chronic inflammatory condition of the bladder or bladder epithelium permeability to toxic agents from the urine.
Both CPPS and interstitial cystitis, which may be related to one another epidemiologically, are treated symptomatically. It should also be noted that it is possible that many men who were diagnosed as CPPS sufferers in reality had interstitial cystitis, and thus, similar treatment may be warranted for both of these conditions. Treatment methods include oral drug therapy, bladder hydrodistension, bladder drug instillation, massage therapy, laser treatments, biofeedback, diet, and even surgery. While some of these methods are partially successful, often the symptoms are not fully alleviated or return shortly after treatment. There are also urinary tract sensory disorders such as overactive bladder or detrusor-sphincter dyssynergia, both of which may be manifested in the urethra and the bladder. Current drug therapies are insufficient, and thus, there is a need for new treatments and treatment methods.
It has been recognized by physicians that applying heat to the prostate may be helpful in easing some of the symptoms associated with CPPS. Heat therapy has been administered in the form of transrectal microwave hyperthermia (temperatures between 41 and 45 degrees Celsius), transurethral microwave hyperthermia, transurethral hot balloon therapy, and transurethral microwave thermotherapy (temperatures over 46 degrees Celsius that cause tissue ablation to exposed tissue).
Hyperthermia treatments have certain advantages, particularly when used in combination with drugs. For example, hyperthermia has been shown to alter intracellular distribution of drugs, while increasing both their metabolism and reaction rates. Hyperthermia provides additional benefits in treatment of cancer, such as transitional cell carcinoma (TCC), or superficial bladder cancer, since it has been shown to increase drug uptake by neoplastic cells while at the same time inhibiting DNA repair in damaged neoplastic cells. However, hyperthermia alone does not necessarily provide long-lasting therapeutic effects because of a lack of sufficient heat supplied by current hyperthermia devices.
It has been shown that heat therapies at higher temperatures, such as transurethral microwave thermotherapy, have better clinical results over the long term, particularly for CPPS. The reason for the beneficial effect is largely unknown, but it has been hypothesized that the higher level of heat in the surrounding non-ablated tissue either improves blood supply or shortens the inflammatory process.
The disadvantage of thermotherapy is that due to the high temperatures near the applicator, a cooling system must be used to protect the urethra while heating the prostate, for example, rendering any system for delivery of thermotherapy relatively bulky and expensive. Additionally, there is a risk of damage to surrounding organs as well as to the prostate itself. Furthermore, microwave heat therapy in particular is problematic in that the radiative energy, which transforms into heat within the tissue, is difficult to control and hard to predict in terms of temperature. Additionally, when hyperthermia is combined with drug treatments, it is essential to avoid excessively high temperatures in order to avoid damage to the drug and its effect on the tissue.
There is thus a widely recognized need for, and it would be highly advantageous to have, a device and method for treatment of CPPS and/or interstitial cystitis for delivery of hyperthermia therapy which is devoid of the above limitations.